Closing the gap in paediatric ventricular assist device therapy with the Berlin Heart EXCOR® 15-ml pump†
OBJECTIVES: The Berlin Heart EXCORVR (EXCOR) paediatric ventricular assist device is used worldwide for mechanical support of infants and small children with end-stage heart failure. A clinically important gap between the smallest EXCOR blood pump (10 ml) and the next larger size (25 ml) limited the...
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| Hauptverfasser: | , |
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| Dokumenttyp: | Article (Journal) |
| Sprache: | Englisch |
| Veröffentlicht: |
23 January 2017
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| In: |
Interactive cardiovascular and thoracic surgery
Year: 2017, Jahrgang: 27, Heft: 5, Pages: 768-771 |
| ISSN: | 1569-9285 |
| DOI: | 10.1093/icvts/ivw437 |
| Online-Zugang: | Verlag, kostenfrei, Volltext: http://dx.doi.org/10.1093/icvts/ivw437 Verlag, kostenfrei, Volltext: https://academic.oup.com/icvts/article-lookup/doi/10.1093/icvts/ivw437 
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| Verfasserangaben: | Fabrizio De Rita, Massimo Griselli, Eugen Sandica, Oliver Miera, Ann Karimova, Yves d’Udekem, Ranny Goldwasser, Katarzyna Januszewska, Antonio Amodeo, Nadine Jurrmann, Simon Ersel and Ares K. Menon |
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| 245 | 1 | 0 | |a Closing the gap in paediatric ventricular assist device therapy with the Berlin Heart EXCOR® 15-ml pump† |c Fabrizio De Rita, Massimo Griselli, Eugen Sandica, Oliver Miera, Ann Karimova, Yves d’Udekem, Ranny Goldwasser, Katarzyna Januszewska, Antonio Amodeo, Nadine Jurrmann, Simon Ersel and Ares K. Menon |
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| 520 | |a OBJECTIVES: The Berlin Heart EXCORVR (EXCOR) paediatric ventricular assist device is used worldwide for mechanical support of infants and small children with end-stage heart failure. A clinically important gap between the smallest EXCOR blood pump (10 ml) and the next larger size (25 ml) limited the choice of pump size in patients with a body surface area (BSA) between 0.33 and 0.5 m2. We present the first clinical experience from the early product surveillance (EPS) of the new EXCOR 15-ml blood pump. METHODS: After CE and U.S. Food and Drug Administration approval in January 2013, 20 patients with a mean age of 1.6 years (range 0.5-3.5 years) and a mean BSA of 0.45 m2 (range 0.33-0.59 m2) were enrolled in the EPS. The main diagnosis was idiopathic cardiomyopathy in 13 patients; the majority (n = 16) of children were in INTERMACS level 1 or 2. Data from high-volume paediatric transplant centres were collected prospectively for a defined follow-up period of 60 days after device implantation.RESULTS: Mean time on the EXCOR 15-ml blood pump was 43 days; the survival rate was 100% at the end of the EPS period. Seven patients underwent a heart transplant from the device; 2 children were weaned; and 11 patients remained on support. Infection of cannula exit sites occurred in 3 patients. Two patients had minor thromboembolic strokes but made a complete neurological recovery.CONCLUSIONS: The new EXCOR 15-ml blood pump demonstrated optimal ventricular assist device support of children with a BSA of 0.33-0.5 m2. | ||
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